Seasonal vaccination with RTS,S/AS01

Journal

The Lancet. Infectious diseases

ISSN: 1474-4457

Titre abrégé: Lancet Infect Dis

Pays: United States

ID NLM: 101130150

Informations de publication

Date de publication:
22 Aug 2023

Historique:

received: 16 03 2023

revised: 31 05 2023

accepted: 01 06 2023

medline: 26 8 2023

pubmed: 26 8 2023

entrez: 25 8 2023

Statut: aheadofprint

Résumé

Seasonal vaccination with the RTS,S/AS01 This was a double-blind, individually randomised, controlled, non-inferiority and superiority, phase 3 trial done at two sites: the Bougouni district and neighbouring areas in Mali and Houndé district, Burkina Faso. Children who had been enrolled in the initial 3-year trial when aged 5-17 months were initially randomly assigned individually to receive SMC with sulphadoxine-pyrimethamine and amodiaquine plus control vaccines, RTS,S/AS01 In April, 2020, of 6861 children originally recruited, 5098 (94%) of the 5433 children who completed the initial 3-year follow-up were re-enrolled in the extension study. Over 5 years, the incidence of clinical malaria per 1000 person-years at risk was 313 in the SMC alone group, 320 in the RTS,S/AS01 Substantial protection against malaria was sustained over 5 years by combining seasonal malaria vaccination with seasonal chemoprevention, offering a potential new approach to malaria control in areas with seasonal malaria transmission. UK Joint Global Health Trials and PATH's Malaria Vaccine Initiative (through a grant from the Bill & Melinda Gates Foundation). For the French translation of the abstract see Supplementary Materials section.

Sections du résumé

BACKGROUND BACKGROUND

Seasonal vaccination with the RTS,S/AS01

METHODS METHODS

This was a double-blind, individually randomised, controlled, non-inferiority and superiority, phase 3 trial done at two sites: the Bougouni district and neighbouring areas in Mali and Houndé district, Burkina Faso. Children who had been enrolled in the initial 3-year trial when aged 5-17 months were initially randomly assigned individually to receive SMC with sulphadoxine-pyrimethamine and amodiaquine plus control vaccines, RTS,S/AS01

FINDINGS RESULTS

In April, 2020, of 6861 children originally recruited, 5098 (94%) of the 5433 children who completed the initial 3-year follow-up were re-enrolled in the extension study. Over 5 years, the incidence of clinical malaria per 1000 person-years at risk was 313 in the SMC alone group, 320 in the RTS,S/AS01

INTERPRETATION CONCLUSIONS

Substantial protection against malaria was sustained over 5 years by combining seasonal malaria vaccination with seasonal chemoprevention, offering a potential new approach to malaria control in areas with seasonal malaria transmission.

FUNDING BACKGROUND

UK Joint Global Health Trials and PATH's Malaria Vaccine Initiative (through a grant from the Bill & Melinda Gates Foundation).

TRANSLATION UNASSIGNED

For the French translation of the abstract see Supplementary Materials section.

Identifiants

DOI: 10.1016/S1473-3099(23)00368-7 PMID: 37625434

pubmed: 37625434

pii: S1473-3099(23)00368-7

doi: 10.1016/S1473-3099(23)00368-7

pii:

doi:

Banques de données

ClinicalTrials.gov

['NCT04319380']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Informations de copyright

Déclaration de conflit d'intérêts

Declaration of interests OO-A is an employee of the GSK group of companies and has restricted shares in the GSK group of companies. All of the authors declare no competing interests.